It’s nice to see that Massachusetts anesthesiologist Scott Reuben has plead guilty to faking medical research and agreed to pay restitution fees for his fraud. But there is one aspect of his plea agreement with federal prosecutors (which he signed last week in the hopes of a more lenient sentence) that troubles me: why is he paying $420,000 in restitution fees to the very drug companies that benefited handsomely from his faked research and rewarded him with speaking fees? (Reuben’s plea deal was first reported in The Day).
To recap, Reuben, an anesthesiologist at Baystate Medical Center in Springfield, fabricated positive data on at least 21 studies of drugs, mostly painkillers such as Vioxx, Bextra and Celebrex; background here. Reuben received research grants from the makers of these drugs, and he was also getting lucrative speaking fees from at least two of the companies: Pfizer (which makes Bextra and Celebrex) and Merck (Vioxx). And now he is required to pay Pfizer $296,000, $16,000 to Wyeth, (now owned by Pfizer), and $49,375 to Merck, all in restitution for taking their money and then faking positive findings about their drugs. Rich, huh? I’m sure these companies are laughing all the way to the bank.
On an equally disturbing note: Jim Dickinson, the editor of FDA Webviews, an industry newsletter that follows the agency, has concluded that the FDA is more pro-business than at any time in 35 years. According to Gooznews, Dickinson writes:
It has taken almost a generation, but by now, the pro-industry infiltration of FDA’s culture is firmly entrenched. Not only is collaboration in product reviews officially encouraged, but good relationships across the regulatory fence hold the prospect of a possible future career in a well-paid industry job.
And what does Dickinson blame for this tectonic shift in the federal agency’s culture? The same culprit I singled out in Side Effects: the Prescription Drug User Fee Act, passed in 1992. I reported that industry user fees now account for more than than half of the FDA’s entire drug review budget and as a result, the agency has become increasingly beholden to the very industry it is supposed to regulate. Or, to quote Dickinson:
User fees at FDA are the primary villain, because they allowed the industry to dictate the changes at the FDA in programs, procedures and practices. It will be impossible for the Obama administration to reverse the trend because as long as the user fees are in place the industry has the upper hand.
Chris Lovell says:
Alison,
While your comments are interesting, you have to go back in time to understand why the Prescription User Fee Act was implemented. Lifesaving drugs were being held up by a bureaucracy that simply couldn't cope with the massive influx of drugs waiting review. AIDS activists were creating significant political pressure to get life saving meds approved faster and user fees made sense in order to speed the approval process. It all made sense at the time and solved a problem. Now we have another political backlash because of drug withdraws resulting in a slowing down of the drug approval process. What do Americans want - Medication approvals and some risk or no drugs and no risk?
Currently the FDA role is assess that a specific drug is safe and effective - that's all. The problem is that Phase III trials often cannot identify side effects that only appear after millions of doses are taken. As all drugs have side effects how can the FDA ensure both long-term surveillance and proper use of the drug? MedWorks speculates that REMS (Risk Evaluation and Mitigation Strategies) and/or Adherence programs will be part of all future drug approvals.
This makes sense for all stakeholders: the pharmaceutical company get approval for their products, the consumer & provider are provided with effective education support and the FDA get a better post approval surveillance program.
Chris Lovell